Ultrasonography-guided and Surgical Rectus Sheath Block in Single-port Access Laparoscopy

• ClinicalTrials.gov Identifier: NCT02431065
• Recruitment Status: Unknown
• First Posted: April 30, 2015
• Last Update Posted: May 4, 2015
• Sponsor: Chungnam National University Hospital
• Information provided by (Responsible Party): Heon-Jong Yoo, Chungnam National University Hospital

Study Description

Brief Summary:

Rectus sheath block is effective in reducing pain in the peri-umbilical region, and the use of ultrasonography is recommended to perform the block at the precise location. Recently, intra-operative rectus sheath block has also been introduced without the aid of ultrasonography. However, no study has not yet compared the analgesic effects of these two different approaches (ultrasonography-guided vs direct surgical). Thus, the aim of our study is to compare the effect of ultrasonography-guided and direct-surgical rectus sheath block after single-port access laparoscopy in benign ovary cyst patients.

Condition or disease	Intervention/treatment	Phase
Pain	Procedure: Rectus sheath block; Drug: Ropivacaine; Other: Normal saline	Phase 2

Detailed Description:

This is a randomized, prospective study comparing the analgesic effects of ultrasonography-guided and direct-surgical rectus sheath block after single-port access laparoscopy in benign ovary cyst patients.

Patients will be randomly divided into 3 groups based on the procedure: control group, ultrasonography group and direct injection group. Each group consists of 30 patients.

• Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.

  • Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.

    • Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.

Analgesic efficiency will be assessed using the VAS (visual analogue scale) pain scale and the total amount of self-administered fentanyl via PCA (patient controlled analgesia) devices at multiple time scales (1, 6, 10, 24 and 48 hours after surgery). We will also compare the incidence of fentanyl complications, such as nausea, vomiting, pruritus and dizziness

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparing the Analgesic Effects of Ultrasonography-guided and Direct-surgical Rectus Sheath Block in Single-port Access Laparoscopy Patients
• Study Start Date: May 2015
• Estimated Primary Completion Date: May 2016
• Estimated Study Completion Date: May 2017

Arms and Interventions

Arm	Intervention/treatment
Experimental: Group 3, Direct injection group; Test group 2, Rectus sheath block will be performed under direct visualization. Ropivacaine (0.75%, 10ml) will be directly injected into the right and left rectus sheath at the end of the operation.	Procedure: Rectus sheath block; Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods: Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.; Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.; Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.; Other Name: anesthesia; Drug: Ropivacaine; Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods: Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.; Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.; Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.; Other Name: surgery
Active Comparator: Group 2, ultrasonography group; Test group 1, Rectus sheath block will be performed under sonographic guidance. Ropivacaine (0.75%, 10ml) will be injected into the right and left rectus sheath under ultrasonographic guidance at the end of the operation.	Procedure: Rectus sheath block; Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods: Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.; Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.; Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.; Other Name: anesthesia; Drug: Ropivacaine; Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods: Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.; Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.; Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.; Other Name: surgery
Placebo Comparator: Group 1; Control group, Rectus sheath block will be performed under sonographic guidance. Normal saline 10 ml will be injected into the right, left rectus sheath under ultrasonography guidance at the end of the operation.	Procedure: Rectus sheath block; Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods: Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.; Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.; Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.; Other Name: anesthesia; Other: Normal saline; Local anesthetics (Ropivacaine 0.75% 10ml) or normal saline (10ml) will be injected in the rectus sheath via different methods: Control group Normal saline 10mL will be injected under ultrasonography guidance into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.; Ultrasonography group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under ultrasonography guidance into the right left rectus sheath at the end of the operation before emergence from general anesthesia.; Direct injection group Local anesthetic (Ropivacaine 0.75% 10 mL) will be injected under direct visualization into the right, left rectus sheath at the end of the operation before emergence from general anesthesia.; Other Name: No intervention

Outcome Measures

Primary Outcome Measures :

1. The intensity of pain as assessed by Dose of fentanyl(opioid) [ Time Frame: within 24 hours of surgery ]
   Dose of fentanyl(opioid) self-administered by the patients within 24 hours of surgery

Secondary Outcome Measures :

1. Incident rate of side effects of fentanyl [ Time Frame: within 24 hours of surgery ]
   Incident rate of side effects of fentanyl including nausea and vomiting by the patients within 24 hours of surgery

Eligibility Criteria

• Ages Eligible for Study: 20 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

1. Patients scheduled for a single port laparoscopic surgery at Chung Nam University hospital due to benign tumor of the ovary or the fallopian tube
2. Between age of twenty to seventy
3. Patients with a physical rating of 1 or 2 according to the American Anesthesiology guidelines
4. Patients who have not had laparoscopic surgery within two months

Exclusion Criteria:

1. Hysterectomy via single port laparoscopic surgery
2. Patients with chronic pelvic pain
3. Abdominal pain of unknown origin
4. Suspected malignant tumor
5. Diagnosed with malignant tumor of any origin
6. Patients currently taking psychiatric medicine
7. Pregnancy
8. Patients with a history of hypersensitivity to amide type local anesthetics
9. Patients with a history of hypersensitivity to opioid
10. Risk of bleeding
11. Unable to comprehend or does not agree to the consent form

Contacts and Locations

Contacts

Contact: Heon Jong Yoo; 82-42-280-8277; bell4184@cnuh.co.kr

Sponsors and Collaborators

Chungnam National University Hospital

Investigators

• Principal Investigator: Heon Jong Yoo, MD. PhD; Chung Nam National University Hospital, clinical vice professor

More Information

Publications:

Crosbie EJ, Massiah NS, Achiampong JY, Dolling S, Slade RJ. The surgical rectus sheath block for post-operative analgesia: a modern approach to an established technique. Eur J Obstet Gynecol Reprod Biol. 2012 Feb;160(2):196-200. doi: 10.1016/j.ejogrb.2011.10.015. Epub 2011 Nov 21.

Osaka Y, Kashiwagi M, Nagatsuka Y, Oosaku M, Hirose C. [Ultrasound-guided rectus sheath block for upper abdominal surgery]. Masui. 2010 Aug;59(8):1039-41. Japanese.

• Responsible Party: Heon-Jong Yoo, Clinical Vice professor, Chungnam National University Hospital
• ClinicalTrials.gov Identifier: NCT02431065
• Other Study ID Numbers: GyAne-1
• First Posted: April 30, 2015
• Last Update Posted: May 4, 2015
• Last Verified: April 2015

Keywords provided by Heon-Jong Yoo, Chungnam National University Hospital:

Rectus sheath block; Single port laparoscopy

Additional relevant MeSH terms:

Ropivacaine; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Anesthetics, Local; Sensory System Agents; Peripheral Nervous System Agents